A Program for the Early Diagnosis and Preventive
Management of Lung Cancer and Chronic Obstructive Lung Disease

2. Prevention | 3. The Early Lung Cancer Action Project (ELCAP) | 4. Results of the ELCAP Study
5. Significance of ELCAP | 6. Advantages of Using EBCT for Lung Cancer Screening
7. The LungScore Program Protocol | 8. Potential Benefits of LungScore
9. Addendum 1- Risk Factors for Developing Lung Cancer
10. Addendum 2- Chronic Obstructive Pulmonary Disease

1. Introduction

Lung cancer is the leading cause of death from cancer in both men and woman in the US, killing approximately 160,000 people in 1998, more than the combined total of the next three highest cancer killers: cancers of the colon, breast and prostate. Lung cancer is so deadly because it has usually spread by the time it is initially diagnosed. Almost 85% are discovered at a late stage, so the cure rate is only 12% . Each year, 172,000 new cases of lung cancer will be detected, and the great majority will be lethal within 1-5 years.

LungScore has been developed in response to exciting new scientific data which suggests that the cure rate for lung cancer may be improved through periodic screening of high risk individuals using low dose CT scanning. Although the scientific study which provides the rationale for LungScore is still in its early stages, the results have been compelling. LifeScore® therefore has designed a program intended to identify lung cancer in its earliest stages, when removal of the tumor has the highest likelihood of being curative.

Back to Top

2. Prevention

"An ounce of prevention is worth a pound of cure."
-Proverb

LifeScore® has developed a proprietary program, called LungScoreÔ, to help in the prevention of lung cancer. LifeScore® uses electron beam CT (EBCT) scanning to identify lung cancer in its earliest stages (less than 5mm), when removal of the tumor has the highest likelihood of being curative. Patients are placed into risk groups based on their scanning results. Patients are scheduled for follow-up to assess whether there are any new nodules and/or growth in existing nodules.

In addition to the lung scan, patients also receive pulmonary function testing. This test reveals whether there are any signs of airway damage from smoking or other causes. This information is incorporated into the final report.

Back to Top

3. The Early Lung Cancer Action Project (ELCAP)

The Early Lung Cancer Action Project (ELCAP) was initiated in 1992 to assess the usefulness of annual low dose radiation CT screening for lung cancer. ELCAP enrolled 1,000 symptom-free volunteers aged 60 years or older, with at least 10 pack-years of cigarette smoking ( i.e.- smoking at least one pack per day for at least 10 years) and no prior history of lung cancer. 522 patients were enrolled at the New York Hospital-Cornell University Medical College and 478 at New York University Medical Center. Chest radiographs and low-dose CT were done for each participant. Dr. Claudia I. Henschke of the Weill Medical College of Cornell University is the lead author on the landmark paper appearing in Lancet . Dr. Henschke has stated that early low dose CT screening could allow as many as 80% of lung cancer patients to survive at least 5 years. Currently, only 15% live that long.

Participants were given both chest x-rays and CT scans. The success rates of both techniques for detecting pulmonary nodules were compared. Results clearly indicated the superiority of CT scanning.

Back to Top

4. Results of the ELCAP Study

Low dose CT scanning found 559 nodules vs. 196 found with chest x-ray. Nodules were divided into benign calcified nodules, or non-calcified nodules. Low dose CT identified 233 patients having from one to six non-calcified nodules. Chest x-ray only identified the non-calcified nodules in 33 of these patients. 23% of patients had non-calcified nodules on low dose CT screening vs. only 7% with chest x-ray screening.

27 patients, or 12% with non-calcified nodules on CT screening, had malignant nodules. 20, or 74% of the CT-detected cases of malignant disease were not detected on chest x-ray. Malignant disease was found four times more frequently on low dose CT than on chest x-ray.

25 patients underwent surgical removal of their tumors. 23 of the tumors (85%) were stage 1. Only four of these had been detected by chest x-ray. Stage 1 tumors were found six times more frequently on low dose CT than with chest x-ray.

Back to Top

5. Significance of ELCAP

Remarkably, 26 (96%) of the 27 CT detected lung cancers were successfully removed surgically. This compared with only 51% on a large prior study done at Mayo Clinic using chest x-ray . The key reason for the high success rate was the ability of low dose CT screening to detect very small (less than 5mm) nodules. The cure rate for lung cancer is inversely proportional to the diameter of nodules detected on screening. Therefore, by using a technology capable of identifying nodules even smaller than 3mm, the LungScore program may dramatically increase the likelihood of finding pulmonary nodules before they reach a size associated with incurable disease.

Back to Top

6. Advantages of Using EBCT for Lung Cancer Screening

Two technologies are available for low dose CT lung cancer screening: helical CT and electron beam CT (EBCT). Helical scanners use 10mm thick slices, while EBCT obtains high resolution 8 mm thick slices. Acquisition time for the full EBCT study is 12 seconds (100ms/slice) vs. 20 seconds for helical CT. The thinner EBCT slices provide higher resolution, and the faster acquisition time minimizes the likelihood of motion artifacts, particularly in the lung areas adjacent to the heart. The ELCAP protocol, which used helical scanners, required follow-up high resolution scans for non-calcified nodules. Because EBCT provides high resolution images, a follow-up scan is not required. EBCT is the ideal imaging technology for identifying small, malignant pulmonary nodules before they achieve a size associated with incurable disease.

Back to Top

7. The LungScore Program Protocol

The LungScore program includes pulmonary function testing and an electron beam CT scan of the lungs.

Program Candidates

The program is indicated for anyone at increased risk of developing lung cancer. This includes:

1. Smokers and ex-smokers (over 10 year smoking history, one or more packs per day).
2. Long exposure to second hand smoke.
3. Significant exposure to asbestos.
4. History of exposure to high levels of radon in the environment.
5. Certain occupational chemical exposure (arsenic, BCME, PAH,etc.)

Scanning Protocol

8mm thickness coaxial slices with 3mm collimation at 8mm increments are obtained beginning at the supraclavicular space and ending at the inferior pole of the adrenal glands. The Imatron Electron Beam Tomography (EBT) scanner performs low dose lung scanning more effectively than other scanners. The 100-millisecond scan speed of EBT allows for coverage of a 300-millimeter lung with 8-millimeter slices in about 12 seconds.
The acquired images are high resolution, low radiation dose, permitting periodic assessments without undue radiation exposure.

Images are reviewed by Dr. Tabita Wright, a board certified radiologist, and Associate Medical Director of LifeScore®.

Interpretation and Follow-Up

The patient is notified of the results of the scan on the next weekday. The patient receives a phone call from Dr. Michael or Dr. Tabita Wright. The patient is sent a letter with the results of the scan. In addition, it is required that the patient provide the name of a physician who will also receive the report.

Flow Chart for Follow-Up Care:

Pulmonary Function Studies

The pulmonary function tests (PFTs) are performed by instructing the patient to blow into a mouthpiece attached to a spirometer. The spirometer measures the air flow velocities and can identify airway problems. Very often, smokers and ex-smokers have subtle airway disease which would not be detected in a physical exam or chest x-ray. By identifying early disease, the test can alert patients to the importance of not smoking, and can also identify patients who should receive flu vaccinations and pneumonia vaccinations. Specific exercise programs may also be indicated to increase lung capacity.

Back to Top

8. Potential Benefits of LungScore

LungScore addresses the critical need for improved survival rates from lung cancer. 25% of Americans are smokers, and rates over the past 30-40 years have been as high as 40%. This will translate into millions of new cases of lung cancer over the next ten years. Once diagnosed, lung cancer is usually fatal. LifeScore® believes that low dose CT screening using EBCT may have the capability to dramatically improve the survival rate from lung cancer. Many hundreds of thousands of lives may be saved through the early detection of small, pre-metastatic pulmonary nodules. LifeScore®'s mission of preventing disease through early diagnosis and expert management will therefore find appropriate expression through its program for the prevention of lung cancer.

Back to Top

9. Addendum 1- Risk Factors for Developing Lung Cancer

85% or more of lung cancer cases occur in people who have a history of smoking tobacco. It is also known that one out of six people who develop lung cancer have never smoked. It has recently been scientifically proven that smoking marijuana and crack-cocaine also increase a person's risk for developing lung cancer.

Smoking
Smoking is the most common cause of lung cancer. The risk is related to the total lifetime exposure to cigarette smoke, and is measured by the number of cigarettes smoked each day, the age at which smoking began, and the number of years a person has smoked.
A smoker's risk of developing lung cancer is reduced by quitting, however, it does not begin to decline until several years after smoking cessation. Ten years after quitting, lung cancer risk in former smokers is about 20% to 50% of those who continue to smoke. Risk continues to decline gradually, however, a former smoker's risk of lung cancer never returns to that of someone who never smoked.

Why should you quit smoking?
1) To slow the progress of other lung disorders such as chronic obstructive pulmonary disease (COPD) and emphysema.
2) To reduce the risk of heart disease (this occurs in two years)
3) You are likely to do better with treatment and surgery - if you are diagnosed with lung cancer.

What about second-hand smoke?
Living with a smoker, or any job that exposes a person to environmental smoke can increase a person's risk of lung cancer. The Environmental Protection Agency estimates that every year 3,000 people in the United States die of lung cancer caused by second-hand smoke.

Age and gender
Historically, lung cancer has tended to occur in older people, predominately those in their 50s, 60s, and 70s. Our immune system works less well as we age, so that cancer cells have a greater chance of slipping through our natural surveillance system undetected.
New studies indicate that women may be more sensitive than men are to carcinogens such as tobacco. Young people, especially females, are now developing lung cancer at increasing rates. This increase will continue as long as people start smoking at young ages.

Genetics
Cancer is now considered to be a disease caused by genes. One of the most striking features of lung cancer is the large number of genetic changes or mutations, often 10 or 20, found in lung cancer cells.

Asbestos
Asbestos workers who smoke have a greatly increased risk of developing lung cancer. Smoking and exposure to asbestos have a multiplicative or synergistic effect on the risk of lung cancer.

Other environmental factors
Exposure to radon, a naturally occurring, colorless, odorless gas that seeps out of the earth's crust, increases the risk of lung cancer. Radon comes from the radioactive decay of uranium. Miners may be at an increased risk if radon is present in the mines where they work. Some people live in areas that have naturally occurring high levels of radon. They may be exposed to radon in their homes, especially in their basement. Kits are commercially available for measuring radon levels.
Other chemicals that are known to increase the risk of lung cancer are arsenic, bis-chloromethyl ether (BCME), chromium and chromium compounds, nickel and nickel compounds, polycyclic aromatric hydrocarbons (PAH), and vinyl chloride. These chemicals are most likely encountered in certain work settings.

10. Addendum 2- Chronic Obstructive Pulmonary Disease

About 14 million Americans are affected by this disease; grouped together, COPD and asthma now represent the fourth leading cause of death in the United States, with over 90,000 deaths reported annually. The death rate from COPD is increasing rapidly, especially among elderly men.
Chronic obstructive pulmonary disease (COPD) is defined as a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, and may be partially reversible. Emphysema and chronic bronchitis must be diagnosed and treated as specific diseases, and most patients with COPD have features of both conditions.

Prevention
COPD is largely preventable. Early recognition of small airways dysfunction in patients who smoke, combined with appropriate treatment and cessation of smoking, may prevent relentless progression of the disease. Early treatment of airway infections and vaccination against influenza and pneumococcal disease may also be of benefit but have no effect on the progression of the disease.

Essentials of diagnosis
1- History of cigarette smoking (most cases).
2- Chronic cough and sputum production (in chronic bronchitis) and difficulty breathing (in emphysema).
3- Abnormal sounds on auscultation of your chest known as rhonchi, decreased intensity of breath sounds, and prolonged expiration on physical examination.
4- Airflow limitation on pulmonary function testing (most cases).

Back to Top